Status:
RECRUITING
In-Utero Endoscopic Correction of Spina Bifida
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
USFetus
Conditions:
Neural Tube Defects
Spina Bifida
Eligibility:
FEMALE
18-52 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneou...
Eligibility Criteria
Inclusion
- Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
- Maternal age ≥18 years.
- Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
- Balanced karyotype and/or normal mircoarray with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
- Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
- Positive evaluation from pediatric neurology consult.
- Willing to return to our center, or to a multi-disciplinary spina bifida clinic closer to their home for the 6, 12, 24, 30, 48, and 60 months follow-up evaluations.
Exclusion
- Multiple gestation
- Insulin-dependent pregestational diabetes
- Presence of a fetal anomaly not related to Chiari II Malformation. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
- Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
- Presence of uterine cervical cerclage or history of incompetent cervix.
- Placenta previa or placental abruption.
- Short cervix \< 25 mm measured by cervical ultrasound.
- Obesity as defined by body mass index (BMI) of 40 or greater.
- History of previous spontaneous singleton delivery prior to 37 weeks.
- Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
- Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.
- Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
- Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
- Other maternal medical condition which is a contraindication to surgery or anesthesia.
- Patient does not have a support person (e.g., husband, partner, parents).
- Inability to comply with the travel and follow-up requirements of the study.
- Patient does not meet psychosocial criteria as determined by the social worker evaluation.
- Participation in another intervention study that influences maternal and fetal morbidity and mortality.
- Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).
- Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.
- Nickel allergy.
- Maternal request to undergo open fetal surgery for the antenatal correction of OSB at our institution primarily or after failed fetoscopic approach.
- Known maternal hypersensitivity to bovine collagen or chondroitin materials.
Key Trial Info
Start Date :
November 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2031
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04362592
Start Date
November 2 2018
End Date
October 31 2031
Last Update
March 28 2025
Active Locations (2)
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1
Hollywood Presbyterian Medical Center
Los Angeles, California, United States, 90027
2
Wellington Regional Medical Center
Wellington, Florida, United States, 33141